Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
QNU · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.6000
Classification
FDA Product Code
QNU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 874.6000
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.